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K Number
K091017
Device Name
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
Manufacturer
CARDICA, INC.
Date Cleared
2009-04-29

(20 days)

Product Code
FZP
Regulation Number
878.4300
Type
Special
Panel
SU
Reference & Predicate Devices
K081225
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cardica® PAS-Port® Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.

Device Description

The Cardica® PAS-Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS-Port® Proximal Anastomosis System consists of a connector and a delivery system.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This is a 510(k) summary for a medical device (PAS-Port® Proximal Anastomosis System) seeking substantial equivalence to a predicate device.

The document focuses on:

  • Device identification and categorization: Trade name, common name, classification, regulation number.
  • Predicate device: K081225.
  • Device description: How it works for aortic vein graft anastomosis.
  • Indications for Use: To create the aortic anastomosis of aortic autologous vein grafts.
  • Comparison to predicate device: Stating substantial equivalence and similarity in indications for use and technological characteristics.
  • Device Testing Results and Conclusion: A general statement that in vitro and in vivo testing was performed to ensure substantial equivalence, safety, and effectiveness. However, specific acceptance criteria, study designs, or actual performance metrics are not detailed.
  • FDA Clearance Letter: Confirming substantial equivalence based on the provided information.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set information. These details are typically part of a more extensive submission package to the FDA, not usually included in the public 510(k) summary.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.